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FDA grants Priority Review for venetoclax NDA

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Additional Relevant Details “Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukaemia,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options.” A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. A Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA).
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Catalyst Date
Occurred on:
Jan 12, 2016
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Related Keywords Fda, Priority Review, Venetoclax, Nda